In 1996, the Health Insurance Portability and Accountability Act (HIPAA) defined standards for safeguarding all patients' sensitive and confidential data. The act requires health insurance providers to enforce strict privacy and security rules, each designed to protect the patient and all electronically protected health information, known as ePHI.
Since then, these rules implemented by the U.S. Department of Health and Human Services have changed how medical services associations and organizations handle safeguarding patient data and information. Healthcare organizations that are effective in following HIPAA prerequisites, regulating serious inside shows, and investing basic energy in ensuring the adequacy and sufficiency of the healthcare programming framework and software system.
The healthcare domain doesn’t excuse errors, as they directly relate to risking an individual's life. Let's say any misinterpreted result may lead to the wrong medicine prescription, inappropriate treatment, or no treatment.
That puts much pressure on healthcare software testing, especially for a QA team not fully versed in all HIPAA compliance requirements. Furthermore, extreme outcomes across the business can be the consequences of not thoroughly testing, where your software teams can be anxious, confused, and disappointed from one development cycle to the next.
The most effective method of overcoming fear is education. While HIPAA requirements can be intimidating at first glance, many of these obligated conditions are identical to already established best practices for protecting information across all software applications. By knowing what is expected and what must be done to maintain these expectations, your team can implement software testing strategies that guide your testers toward success.
What It Means to be HIPAA-Compliant
Am I HIPAA-compliant? This is something that every healthcare organization must ask and keep a check on themselves regularly to ensure that all internal practices and procedures work in the best interest of the patients.
To be HIPAA compliant means to protect ePHI throughout your system and any information exchange by upholding the strict, strongest privacy and security protocols.
HIPAA requirements revolve around these five rules:
- HIPAA Privacy Rule: The focus is on the patient's right to privacy. All involved healthcare entities and providers, business associates, and clearing houses must protect patient data such as medical records, financial information, Social Security Numbers, addresses, etc. Additionally, it should set limits and conditions on the uses and disclosures within the system that may be made without patient authorization.
- HIPAA Security Rule: The focus is to standardize the measures that ensure the confidentiality, integrity, and availability of ePHI through technical, physical, and administrative safeguards.
So, appropriate technical (e.g., implementing access control, introducing activity logs and audit controls), physical (e.g., facility access control, workstation use, and device security), and administrative (e.g., setting up a security management process and security incident procedures) safeguards are in place that ensure the security, confidentiality, and integrity of ePHI.
- HIPAA Enforcement Rule: Not following HIPAA compliance requirements leads to investigations, penalties, and/or procedures for hearings.
- HIPAA Breach Notification Rule: Notify patients and the United States Department of Health & Human Services when unsecured ePHI breaches. Notify the media when a breach impacts more than 500 patients.
- HIPAA Omnibus Rule: The rule typically impacts business associates. It came into effect on January 25, 2013, and modifies and supplements all the previously available rules. Furthermore, the changes spell out the obligations of physicians and other healthcare professionals regarding PHI protection.
How to comply with HIPAA in Software Testing
Assuming you're inquiring, "Am I HIPAA consistent?" If you can't say, "I am HIPAA compliant," your software testing methods probably need to be rethought. Your team must be aware of the specific HIPAA regulations when entering the healthcare industry so that they can be incorporated into your HIPAA testing strategy.
As you gear up for healthcare software testing, incorporate these proven strategies to ensure full compliance:
1. Access Control
Following HIPAA compliance requirements, a user should be permitted to get to just the base or minimum measure of data expected to follow through with a given responsibility. Strict access control can be achieved with multiple approaches, like restricted user access, tracking user identity, multi-factor authentication, etc.
2. Encrypted Data Transfers
All data shared among users should be encrypted completely and decrypted by authorized users only. The same applies to data stored elsewhere, such as in the cloud.
Following testing, you should perform a risk analysis to identify data loss during transfers or unauthorized access attempts. To uphold HIPAA requirements, use best practices for transferring encrypted data.
3. Data Sanitization
There’s always a possibility of data leakage when performing application testing in a healthcare organization. In this tech-savvy world, data is stored on different platforms like laptops, tablets, smartphones, and other mobile devices and is prone to cyber-attacks. So, any efforts to destroy or remove this information from devices can be a positive step in preventing data loss from intrusions.
To prevent this, make it a standard practice to create test data that mimics what is expected from real data without compromising patient information.
4. Audit Trail
Implement an audit trail to monitor all actions involving patient data to abide by HIPAA compliance requirements. This includes modifications, deletions, additions, and just about any other action you can imagine.
5. Failover/Load Balancing
This is perhaps the most vital reason to uphold HIPAA requirements, as patient data loss can put a life on the line. Failover plans and load balancing verify the system's ability to continue day-to-day operations while backups are performed.
In conjunction with the approaches mentioned above, the strategies below can also be followed for HIPAA compliance testing:
- Security and Penetration Testing: It must be carried out to ensure the integrity of the patient data. Any unforeseen issues or risks involved can be mitigated well in advance. In this strategy, QA engineers pose as hackers to identify the bottlenecks in software and prevent cyber breaches in the near future.
- Sanity Testing: It involves testing if the authenticated user is able to access the application easily, has a granted view, and can perform actions like modification and deletion. Also, the sanity of the data stored or retrieved from the database is tested.
- Training and Awareness Program: Another approach is to regularly conduct the HIPAA Privacy and Security Awareness Training Program to inform all employees dealing in the healthcare domain about the HIPAA compliance requirements.
- Structure All Test Data: Standardize or normalize the test data used to verify and validate modules within the application. Data structuring helps define the testing performed at different levels and parameters. It reduces the risk of missing critical aspects of the application and ensures more reliable test results by mimicking real-time scenarios.
In the healthcare domain, the stakes are very high. The HIPAA compliance test ensures that the software/application complies with all the technical safeguards required by HIPAA and doesn’t pose any threats to ePHI privacy. QA team must be aware of the potential consequences of non-compliance, including severe fines, loss of patient trust, and legal repercussions. HIPAA compliance is an ongoing effort that requires diligence and attention to even minute details throughout the software development and testing life cycle. These are a few reasons to pay close attention to your QA team and software testing strategy. The result will be a solid, dependable product, a happy client, and protected patients.
Role of QASource
QASource, a dedicated QA service provider, ensures healthcare software testing aligns with HIPAA compliance. Their expertise enables tailored testing strategies for access control, data encryption, audit trails, and data sanitization. QASource meticulously documents testing processes, offers compliance training, conducts regular audits, and emphasizes risk mitigation through security testing. Collaboration with QASource ensures structured test data management and integration of compliance considerations, resulting in a robust, compliant, and patient-centric healthcare software system.